I used to think the same about Mr. Black and wondered what his value is to NWBO. Upon information and belief, I think Mr. Black may be the most important of any of the board members and because of his intel has assured that NWBO will be treated fairly and with reasonable dispatch by the FDA.
The singular and most important goal for NWBO is to obtain regulatory approvals. And...the most important agency is NWBO's own national agency, the FDA.
Upon information and belief, the hold and its length of imposition was due to unsavory elements within the FDA and was finally lifted when higher management eschalons were confronted with Intel/evidence of corruption, conspiracies and illegal actions flowing therefrom by Mr. Black and his operatives. NWBO reached an agreement with the agency that it would be treated fairly and impartially and with reasonable expedition. The top management of the FDA wanted to avoid a scandal and NWBO wanted assurances that its application would be treated strictly on its merits. As part of a win-win compromise, the FDA agreed to re-examine its decisional criteria with respect to novel therapeutic approaches with substantial input from NWBO and NWBO modified its SAP in accordance with the new and much more flexible guidelines.
While NWBO has a certain leverage wrt the FDA, it is important that they show undeniable results that minimize if not eliminate any questions and, accordingly, NWBO is double and even triple checking the data and its accuracy and making sure that it has all the necessary data collected before data lock. NWBO wants to avoid, at all costs, regulatory delays in approvals such as, for example, a CRL which in itself could cause considerable delays and even engender a phase IV trial, not to mention the severe impact upon the SP and ithe ability to obtain favorable financing.
If the foregoing is a roughly accurate broad picture of what has transpired, Mr. Black has much more than earned his keep. We may never know the full story due to the players involved but can thank Mr. Black for his crucial,role in helping NWBO across the goal line.
In any event, I think Mr. Black has played and is playing a very important but very clandestine role in assuring to all extents possible NWBO' obtaining FDA approvals. Les has mentioned several times that NWBO's Intel is very good and not to sell Cofer Black short. I think there is something to that. Just a thought FWIW.
